BEUDAMED
    FDA Enforcement Class II Ongoing

    Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

    Recall: Z-2635-2023 · Reported October 4, 2023

    Enforcement

    Recall Number
    Z-2635-2023
    Event ID
    92973
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Kabi USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 4, 2023
    Initiation Date
    April 22, 2022
    Classification Date
    September 25, 2023
    Address
    50 High St Ste 50, N/A, North Andover, MA, 01845-2620, United States

    Description

    Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

    Reason

    Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set

    Code Info

    (UDI): 00811505030122 Software Version: 5.0.0 and 5.0.1

    Distribution

    US Nationwide distribution in the states of NJ, WI.

    Quantity

    1344 pumps